Safety and Toxicology Services Brochure
Frontage offers an impressive suite of services to take lead candidate drugs to the IND stage. With Experimur’s acquisition, Frontage now has significantly expanded our range of services, supporting customers’ drug-development programs beyond IND and into NDA-enabling toxicology studies. Frontage has exceptional bioanalytical supporting capabilities for small molecules, large molecules, and biomarkers.
Rapid, accurate and highly customizable assay platforms for pharmacogenomic studies
The diagnosis and treatment of human diseases and the development of new drugs increasingly rely on our ability to determine patient genotypes using accurate and sensitive pharmacogenomic tests. Many PCR and next-generation sequencing (NGS) based assay platforms are currently available.
However, the type of DNA sequence variants, the number targets and the sensitivity requirements are highly diverse in different studies. Here we describe the design, performance and regulatory considerations of several assay platforms that are accurate, high-throughput, cost effective and customizable. These platforms provide high-quality pharmacogenomic data ideally suited to meet the needs of individual studies.
Guidelines for Developmental and Reproductive Toxicity (DART) Testing
This webinar will provide a general overview of the regulatory guidelines required for developmental and reproductive toxicity (DART) testing. In order to initiate clinical trials for women of child-bearing potential (WOCBP), the FDA requires initiation of preclinical DART studies using mammalian research models. These regulated studies provide important information regarding the effects of drug exposures prior to and during parental mating, as well as evaluating maternal and fetal changes during gestation, and identifying any alterations in the development of the offspring following birth.
6 Reasons To Do Exploratory Toxicology for Successful GLP Studies
Performing robust exploratory tests upfront can save time and money later on in the process. This infographic outlines the top reasons for why clients are encouraged to consider a comprehensive exploratory toxicology program and how it can provide success in GLP studies.
DART Fact Sheet
Regulated preclinical developmental and reproductive toxicity (DART) studies using mammalian research models are an important step to take before initiating clinical trials. Frontage’s scientists have over 20 years of experience running DART studies with knowledge of accurately estimating test doses, showing formulation stability, and expertise in animal handling. Our labs have the extensive capacity to run many studies, helping our sponsors meet their timelines with uncompromising quality.